Clincosm LogoSign in Get a demo

FINITE CHB: Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01320943
Collaborator
(none)
43
Enrollment
13
Locations
2
Arms
63.9
Actual Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss and seroconversion in participants who stop tenofovir disoproxil fumarate (TDF) (Stop TDF arm) compared to participants who continue TDF (Continue TDF arm).

Only participants who already are on treatment with TDF monotherapy or TDF in combination with lamivudine or emtricitabine for at least 4 years and who achieved and maintained virologic suppression (< 400 copies/mL) for 3.5 or more years will be included in this study. One treatment arm will stop the TDF therapy while the other treatment arm will continue the TDF therapy. Participants in the Stop TDF arm will be monitored very closely with special focus on biochemical flares (especially alanine aminotransferase (ALT) increases) and virological relapses (Hepatitis B viral load increases). If any participant in the Stop TDF arm exceeds one or more predefined limits for such flares or relapses, TDF treatment will be reinstituted.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
FINITE CHB - First Investigation in Stopping Tenofovir Disoproxil Fumarate (TDF) Treatment After Long Term Virologic Suppression in HBeAg-negative Chronic Hepatitis B
Actual Study Start Date :
Apr 26, 2011
Actual Primary Completion Date :
Jul 28, 2016
Actual Study Completion Date :
Aug 23, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stop TDF

Participants randomized to this arm will stop TDF therapy at baseline.

Other: Stop TDF
Participants will stop TDF therapy
Active Comparator: Continue TDF

Participants randomized to this arm will continue TDF therapy.

Drug: TDF
Tenofovir disoproxil fumarate (TDF) 300 mg tablet administered orally once daily
Other Names:
  • Viread®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Participants With HBsAg Loss at Week 144 in Both Study Arms [Week 144]

      HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.

    Secondary Outcome Measures

    1. Proportion of Participants With HBsAg Seroconversion in Both Study Arms at Weeks 96 and 144 [Weeks 96 and 144]

      HBsAg seroconversion is defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. Proportions are based on the Kaplan-Meier estimate.

    2. Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms [Baseline to Week 144]

      The analyses were summarized by 3 treatment subgroups: Stop TDF (TDF-Free), Restart TDF, and Continue TDF When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. For Restart TDF group, baseline is defined as the last available record on or prior to the restart date of TDF.

    3. Proportion of Participants Who Restart TDF Therapy in the Stop TDF Arm [Weeks 48, 96, and 144]

    4. Percentage of Participants With Viral Suppression in the Stop TDF Arm (TDF-Free and Re-Start TDF Groups) [Baseline to Week 144]

      Viral suppression is defined as 2 consecutive assessments of HBV DNA < 400 copies/mL (69 IU/mL) through Week 144.

    5. Percentage of Participants With Alanine Aminotransferase (ALT) > Upper Limit of the Normal Range in the Stop TDF Arm (TDF-Free and Restart TDF) [Baseline to Week 144]

    6. Proportion of Participants With HBsAg Loss at Week 96 in Both Study Arms [Week 96]

      HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Chronic hepatitis B, hepatitis B e-antigen negative, hepatitis B e-antibody positive, and hepatitis B surface antigen-positive

    • Hepatitis B e Antigen (HBeAg)-negative at the beginning of TDF therapy (i.e. TDF monotherapy or combination of TDF + lamivudine or TDF + emtricitabine)

    • Received continuous TDF therapy (i.e. TDF monotherapy or combination of TDF + lamivudine or TDF + emtricitabine) treatment for at least 4 years prior to screening. If TDF has been used in combination with lamivudine or emtricitabine, lamivudine or emtricitabine must have been stopped at least 12 weeks prior to screening

    • Documented hepatitis B virus DNA (HBV DNA) < 400 copies/mL for at least 3.5 years prior to screening and at screening

    • ALT within normal range

    • α-fetoprotein (AFP) <= 50 ng/mL

    • Calculated creatinine clearance >= 70 mL/min by Cockcroft-Gault formula using ideal body weight

    • <= 10 kPa on Fibroscan assessment

    • A negative serum pregnancy test for female subjects

    • Adult subjects >= 18 years of age

    Key Exclusion Criteria:

    • Known cirrhosis

    • Evidence of fibrosis >= Stage 3 (METAVIR) on liver biopsy or Fibroscan > 10 kPa within 6 months prior to screening

    • Documentation of confirmed episodes (i.e., 2 consecutive values) of HBV DNA > 400 copies/mL within 3.5 years prior to screening

    • History of decompensated liver disease (defined as direct [conjugated] bilirubin > 1.5 x upper limit of normal, prothrombin time (PT) > 1.5 x upper limit of normal, platelets < 75,000/mm³, serum albumin < 3.0 g/dL

    • History of clinical hepatic decompensation in the judgement of the investigator

    • Evidence of hepatocellular carcinoma

    • Significant bone disease (in the judgment of the investigator)

    • Serological evidence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus, or hepatitis D infection

    • Known hypersensitivity to TDF, its metabolites, or formulation excipients

    • Concomitant therapy with disallowed medications

    • History of malignant disease

    • Lactating females

    • Females wishing to became pregnant during the duration of the stud

    • Subjects participating in another clinical trial can only be enrolled at the discretion of the Medical Monitor

    Note: Other protocol defined inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Leberzentrum am Checkpoint Berlin Germany 10969
    2 Charite CVK Berlin Germany 13353
    3 Zentrum für HIV und Hepatitis Duesseldorf Germany 40237
    4 J.W. Goethe Universitaetsklinikum Frankfurt Germany 60590
    5 ifi Studien und Projekte GmbH Hamburg Germany 20099
    6 Universitaetsklinikum Hamburg Eppendorf Hamburg Germany 20246
    7 Medizinische Hochschule Hannover Hannover Germany 30625
    8 Universitaetsklinik Heidelberg Heidelberg Germany 69120
    9 Gastroenterologische Gemeinschaftspraxis Herne Germany 44623
    10 Universitaetsklinikum Leipzig Leipzig Germany 04103
    11 Gemeinschaftspraxis Gastroenterologie Leverkusen Germany 51375
    12 Klinikum der LMU Grosshadern Muenchen Germany 81377
    13 Universitaetsklinikum Ulm Ulm Germany 89081

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01320943
    Other Study ID Numbers:
    • GS-EU-174-0160
    • 2010-021925-12
    First Posted:
    Mar 23, 2011
    Last Update Posted:
    Aug 29, 2017
    Last Verified:
    Jul 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Gilead Sciences
    stopping oral antiviral therapy
    HBsAg loss
    seroconversion
    restarting oral antiviral therapy
    Additional relevant MeSH terms:
    Hepatitis B
    Hepatitis B, Chronic
    Hepatitis
    Hepatitis, Chronic

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at 13 study sites in Germany. The first participant was screened on 26 April 2011. The last study visit occurred on 23 August 2016.
    Pre-assignment Detail 65 participants were screened.
    Arm/Group Title Stop TDF Continue TDF
    Arm/Group Description Participants stopped tenofovir disoproxil fumarate (Viread®; TDF) monotherapy at baseline. Participants continued TDF monotherapy 300 mg once daily.
    Period Title: Overall Study
    STARTED 21 22
    COMPLETED 20 20
    NOT COMPLETED 1 2

    Baseline Characteristics

    Arm/Group Title Stop TDF Continue TDF Total
    Arm/Group Description Participants stopped tenofovir disoproxil fumarate (Viread®; TDF) monotherapy at baseline. Participants continued TDF monotherapy 300 mg once daily. Total of all reporting groups
    Overall Participants 21 21 42
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    44.6
    (10.51)
    45.0
    (7.06)
    44.8
    (8.85)
    Sex: Female, Male (Count of Participants)
    Female
    3
    14.3%
    6
    28.6%
    9
    21.4%
    Male
    18
    85.7%
    15
    71.4%
    33
    78.6%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    1
    4.8%
    1
    4.8%
    2
    4.8%
    Black or African American
    1
    4.8%
    0
    0%
    1
    2.4%
    White
    18
    85.7%
    19
    90.5%
    37
    88.1%
    Other
    1
    4.8%
    1
    4.8%
    2
    4.8%
    Hepatitis B Virus Surface Antigen (log10 IU/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 IU/mL]
    4.4
    (0.71)
    4.5
    (0.35)
    4.5
    (0.56)

    Outcome Measures

    1. Primary Outcome
    Title Proportion of Participants With HBsAg Loss at Week 144 in Both Study Arms
    Description HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
    Time Frame Week 144

    Outcome Measure Data

    Analysis Population Description
    HBsAg Loss and Seroconversion Full Analysis Set: participants in the Full Analysis Set who had at least one post-baseline HBsAg value and with HBsAg positive and HBsAb negative or missing at baseline.
    Arm/Group Title Stop TDF Continue TDF
    Arm/Group Description Participants stopped tenofovir disoproxil fumarate monotherapy at baseline. Participants continued TDF monotherapy 300 mg once daily.
    Measure Participants 21 21
    Number (95% Confidence Interval) [Proportion of participants]
    0.236
    1.1%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Stop TDF, Continue TDF
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.022
    Comments Log-rank test statistic was used to compare the time to HBsAg loss between the two treatment arms.
    Method Log Rank
    Comments
    2. Secondary Outcome
    Title Proportion of Participants With HBsAg Seroconversion in Both Study Arms at Weeks 96 and 144
    Description HBsAg seroconversion is defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. Proportions are based on the Kaplan-Meier estimate.
    Time Frame Weeks 96 and 144

    Outcome Measure Data

    Analysis Population Description
    HBsAg Loss and Seroconversion Full Analysis Set: participants in the Full Analysis Set who had at least 1 post-baseline HBsAg value and with HBsAg positive and HBsAb negative or missing at baseline.
    Arm/Group Title Stop TDF Continue TDF
    Arm/Group Description Participants stopped tenofovir disoproxil fumarate monotherapy at baseline. Participants continued TDF monotherapy 300 mg once daily.
    Measure Participants 21 21
    HBsAg Seroconversion at Week 96
    0.056
    0.3%
    0
    0%
    HBsAg Seroconversion at Week 144
    0.203
    1%
    0
    0%
    3. Secondary Outcome
    Title Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms
    Description The analyses were summarized by 3 treatment subgroups: Stop TDF (TDF-Free), Restart TDF, and Continue TDF When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. For Restart TDF group, baseline is defined as the last available record on or prior to the restart date of TDF.
    Time Frame Baseline to Week 144

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set ( participants who were randomized to Stop TDF arm and had a baseline visit or who were randomized to Continue TDF arm and received at least 1 dose of study drug) with available data were analyzed.
    Arm/Group Title Stop TDF (TDF-Free) Restart TDF Continue TDF
    Arm/Group Description Participants who stopped TDF monotherapy at baseline. Participants in this group were TDF free. Stop TDF participants who restarted TDF therapy Participants who continued TDF monotherapy 300 mg once daily.
    Measure Participants 21 8 21
    Change from Baseline at Week 2
    -0.03
    (0.139)
    NA
    (NA)
    Change from Baseline at Week 4
    -0.03
    (0.170)
    -0.01
    (0.105)
    Change from Baseline at Week 6
    -0.02
    (0.192)
    NA
    (NA)
    Change from Baseline at Week 8
    0.04
    (0.500)
    NA
    (NA)
    Change from Baseline at Week 10
    0.01
    (0.556)
    NA
    (NA)
    Change from Baseline at Week 12
    -0.11
    (0.621)
    -0.03
    -0.02
    (0.137)
    Change from Baseline at Week 16
    -0.35
    (0.741)
    -0.73
    (0.438)
    NA
    (NA)
    Change from Baseline at Week 20
    -0.48
    (0.949)
    -0.42
    NA
    (NA)
    Change from Baseline at Week 24
    -0.56
    (1.029)
    -1.41
    (1.211)
    -0.07
    (0.139)
    Change from Baseline at Week 28
    -0.60
    (0.969)
    -0.88
    (0.916)
    NA
    (NA)
    Change from Baseline at Week 32
    -0.77
    (1.126)
    -0.96
    (1.211)
    NA
    (NA)
    Change from Baseline at Week 36
    -0.67
    (1.151)
    -0.26
    (0.461)
    -0.08
    (0.140)
    Change from Baseline at Week 40
    -0.78
    (1.198)
    -0.97
    (1.275)
    NA
    (NA)
    Change from Baseline at Week 44
    -0.87
    (1.238)
    -0.59
    NA
    (NA)
    Change from Baseline at Week 48
    -0.88
    (1.314)
    -1.01
    (1.295)
    -0.11
    (0.101)
    Change from Baseline at Week 60
    -0.96
    (1.353)
    -1.03
    (1.236)
    -0.10
    (0.133)
    Change from Baseline at Week 72
    -1.22
    (1.478)
    -0.64
    (1.085)
    -0.14
    (0.142)
    Change from Baseline at Week 84
    -1.21
    (1.555)
    -0.69
    (1.084)
    -0.16
    (0.164)
    Change from Baseline at Week 96
    -1.22
    (1.530)
    -0.69
    (1.031)
    -0.17
    (0.159)
    Change from Baseline at Week 108
    -1.43
    (1.573)
    -0.69
    (1.088)
    -0.17
    (0.145)
    Change from Baseline at Week 120
    -1.56
    (1.752)
    -0.58
    (0.870)
    -0.20
    (0.136)
    Change from Baseline at Week 132
    -1.74
    (1.829)
    -0.52
    (0.941)
    -0.22
    (0.172)
    Change from Baseline at Week 144
    -1.80
    (1.796)
    -0.51
    (0.861)
    -0.22
    (0.160)
    4. Secondary Outcome
    Title Proportion of Participants Who Restart TDF Therapy in the Stop TDF Arm
    Description
    Time Frame Weeks 48, 96, and 144

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS): participants who were randomized to Stop TDF group and had a baseline visit or who were randomized to Continue TDF group and received at least 1 dose of study drug. Proportions are based on the Kaplan-Meier estimate.
    Arm/Group Title Stop TDF
    Arm/Group Description Participants stopped TDF monotherapy at baseline.
    Measure Participants 21
    TDF Restart at Week 48
    0.143
    0.7%
    TDF Restart at Week 96
    0.238
    1.1%
    TDF Restart at Week 144
    0.381
    1.8%
    5. Secondary Outcome
    Title Percentage of Participants With Viral Suppression in the Stop TDF Arm (TDF-Free and Re-Start TDF Groups)
    Description Viral suppression is defined as 2 consecutive assessments of HBV DNA < 400 copies/mL (69 IU/mL) through Week 144.
    Time Frame Baseline to Week 144

    Outcome Measure Data

    Analysis Population Description
    Participants in the FAS with available data were analyzed. When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. 1 participant restarted TDF during Wk 72, thus was reported in both Stop TDF and Restart TDF arms based on the TDF restart date.
    Arm/Group Title Stop TDF (TDF-Free) Re-Start TDF
    Arm/Group Description Participants stopped TDF monotherapy at baseline. Participants in this group were TDF free. Stop TDF participants who restarted TDF therapy
    Measure Participants 21 8
    Week 2
    52.4
    249.5%
    Week 4
    5.3
    25.2%
    Week 6
    10.0
    47.6%
    Week 8
    5.0
    23.8%
    Week 10
    15.0
    71.4%
    Week12
    21.1
    100.5%
    0
    0%
    Week 16
    31.6
    150.5%
    0
    0%
    Week 20
    27.8
    132.4%
    0
    0%
    Week 24
    16.7
    79.5%
    0
    0%
    Week 28
    17.6
    83.8%
    0
    0%
    Week 32
    12.5
    59.5%
    66.7
    317.6%
    Week 36
    29.4
    140%
    100.0
    476.2%
    Week 40
    22.2
    105.7%
    100.0
    476.2%
    Week 44
    29.4
    140%
    100.0
    476.2%
    Week 48
    27.8
    132.4%
    100.0
    476.2%
    Week 60
    33.3
    158.6%
    100.0
    476.2%
    Week 72
    35.3
    168.1%
    60.0
    285.7%
    Week 84
    31.3
    149%
    100.0
    476.2%
    Week 96
    37.5
    178.6%
    100.0
    476.2%
    Week 108
    37.5
    178.6%
    100.0
    476.2%
    Week 120
    40.0
    190.5%
    71.4
    340%
    Week 132
    38.5
    183.3%
    100.0
    476.2%
    Week 144
    46.2
    220%
    87.5
    416.7%
    6. Secondary Outcome
    Title Percentage of Participants With Alanine Aminotransferase (ALT) > Upper Limit of the Normal Range in the Stop TDF Arm (TDF-Free and Restart TDF)
    Description
    Time Frame Baseline to Week 144

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed. Percentages are based on the number of participants with non-missing laboratory test results at each visit. One participant restarted TDF during Weeks 72 and 120 and thus was reported in both the Stop TDF and Re-Start TDF groups based on the date of TDF restart.
    Arm/Group Title Stop TDF (TDF-Free) Re-Start TDF
    Arm/Group Description Participants who stopped TDF monotherapy at baseline. Participants in this group were TDF free. Stop TDF participants who restarted TDF therapy
    Measure Participants 21 8
    Week 2
    4.8
    22.9%
    Week 4
    0
    0%
    Week 6
    35.0
    166.7%
    Week 8
    60.0
    285.7%
    Week 10
    70.0
    333.3%
    Week 12
    42.1
    200.5%
    100.0
    476.2%
    Week 16
    26.3
    125.2%
    100.0
    476.2%
    Week 20
    11.8
    56.2%
    100.0
    476.2%
    Week 24
    16.7
    79.5%
    50.0
    238.1%
    Week 28
    11.8
    56.2%
    33.3
    158.6%
    Week 32
    13.3
    63.3%
    0
    0%
    Week 36
    11.8
    56.2%
    0
    0%
    Week 40
    23.5
    111.9%
    0
    0%
    Week 44
    11.8
    56.2%
    0
    0%
    Week 48
    16.7
    79.5%
    0
    0%
    Week 60
    22.2
    105.7%
    0
    0%
    Week 72
    11.8
    56.2%
    40
    190.5%
    Week 84
    18.8
    89.5%
    0
    0%
    Week 96
    12.5
    59.5%
    0
    0%
    Week 108
    18.8
    89.5%
    0
    0%
    Week 120
    20.0
    95.2%
    14.3
    68.1%
    Week 132
    0
    0%
    28.6
    136.2%
    Week 144
    15.4
    73.3%
    0
    0%
    7. Secondary Outcome
    Title Proportion of Participants With HBsAg Loss at Week 96 in Both Study Arms
    Description HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
    Time Frame Week 96

    Outcome Measure Data

    Analysis Population Description
    HBsAg Loss and Seroconversion Full Analysis Set
    Arm/Group Title Stop TDF Continue TDF
    Arm/Group Description Participants stopped TDF monotherapy at baseline. Participants continued TDF monotherapy 300 mg once daily.
    Measure Participants 21 21
    Number (95% Confidence Interval) [Proportion of participants]
    0.172
    0.8%
    0
    0%

    Adverse Events

    Time Frame Up to 144 weeks
    Adverse Event Reporting Description Safety Analysis Set TDF-emergent Events (Restart TDF and Continue TDF): events began on/after date of TDF restart until last dose day for subjects who restarted TDF in the Stop TDF group and on/after Study Day 1 until last dose day for subjects in the Continue TDF group Termination-emergent Events (TDF-Free): events began on/after Study Day 1 for the Stop TDF group until last study day for subjects who did not restart TDF and prior to date of restart for subjects who restarted TDF
    Arm/Group Title Stop TDF (TDF-Free) [Termination Emergent] Re-start TDF [TDF Emergent] Continue TDF [TDF Emergent]
    Arm/Group Description Participants stopped TDF monotherapy at baseline. Stop TDF participants who restarted TDF therapy. Participants continued TDF monotherapy 300 mg once daily.
    All Cause Mortality
    Stop TDF (TDF-Free) [Termination Emergent] Re-start TDF [TDF Emergent] Continue TDF [TDF Emergent]
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/21 (0%) 0/8 (0%) 0/21 (0%)
    Serious Adverse Events
    Stop TDF (TDF-Free) [Termination Emergent] Re-start TDF [TDF Emergent] Continue TDF [TDF Emergent]
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/21 (19%) 1/8 (12.5%) 3/21 (14.3%)
    Cardiac disorders
    Acute coronary syndrome 0/21 (0%) 0/8 (0%) 1/21 (4.8%)
    General disorders
    Surgical failure 0/21 (0%) 1/8 (12.5%) 0/21 (0%)
    Hepatobiliary disorders
    Cholelithiasis 0/21 (0%) 0/8 (0%) 1/21 (4.8%)
    Infections and infestations
    Appendicitis 1/21 (4.8%) 0/8 (0%) 0/21 (0%)
    Injury, poisoning and procedural complications
    Facial bones fracture 0/21 (0%) 0/8 (0%) 1/21 (4.8%)
    Limb traumatic amputation 1/21 (4.8%) 0/8 (0%) 0/21 (0%)
    Investigations
    Alanine aminotransferase increased 2/21 (9.5%) 0/8 (0%) 0/21 (0%)
    Psychiatric disorders
    Depression 0/21 (0%) 0/8 (0%) 1/21 (4.8%)
    Other (Not Including Serious) Adverse Events
    Stop TDF (TDF-Free) [Termination Emergent] Re-start TDF [TDF Emergent] Continue TDF [TDF Emergent]
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 17/21 (81%) 6/8 (75%) 16/21 (76.2%)
    Ear and labyrinth disorders
    Vertigo 0/21 (0%) 0/8 (0%) 2/21 (9.5%)
    Gastrointestinal disorders
    Abdominal pain 4/21 (19%) 0/8 (0%) 0/21 (0%)
    Abdominal pain upper 2/21 (9.5%) 0/8 (0%) 0/21 (0%)
    Diarrhoea 2/21 (9.5%) 1/8 (12.5%) 1/21 (4.8%)
    Dyspepsia 2/21 (9.5%) 1/8 (12.5%) 0/21 (0%)
    Gastritis 0/21 (0%) 1/8 (12.5%) 0/21 (0%)
    Haemorrhoids 2/21 (9.5%) 0/8 (0%) 0/21 (0%)
    General disorders
    Fatigue 4/21 (19%) 2/8 (25%) 2/21 (9.5%)
    Influenza like illness 0/21 (0%) 1/8 (12.5%) 1/21 (4.8%)
    Immune system disorders
    Seasonal allergy 2/21 (9.5%) 0/8 (0%) 0/21 (0%)
    Infections and infestations
    Bronchitis 2/21 (9.5%) 0/8 (0%) 2/21 (9.5%)
    Gastroenteritis 2/21 (9.5%) 0/8 (0%) 2/21 (9.5%)
    Nasopharyngitis 11/21 (52.4%) 1/8 (12.5%) 6/21 (28.6%)
    Sinusitis 0/21 (0%) 1/8 (12.5%) 1/21 (4.8%)
    Investigations
    Alanine aminotransferase increased 4/21 (19%) 0/8 (0%) 0/21 (0%)
    Aspartate aminotransferase increased 2/21 (9.5%) 0/8 (0%) 0/21 (0%)
    Blood creatine phosphokinase increased 2/21 (9.5%) 0/8 (0%) 0/21 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 0/21 (0%) 1/8 (12.5%) 0/21 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/21 (0%) 0/8 (0%) 2/21 (9.5%)
    Back pain 4/21 (19%) 1/8 (12.5%) 1/21 (4.8%)
    Musculoskeletal pain 0/21 (0%) 1/8 (12.5%) 2/21 (9.5%)
    Myalgia 0/21 (0%) 0/8 (0%) 2/21 (9.5%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 0/21 (0%) 1/8 (12.5%) 0/21 (0%)
    Keratoacanthoma 1/21 (4.8%) 1/8 (12.5%) 0/21 (0%)
    Nervous system disorders
    Headache 5/21 (23.8%) 1/8 (12.5%) 3/21 (14.3%)
    Renal and urinary disorders
    Haematuria 0/21 (0%) 1/8 (12.5%) 0/21 (0%)
    Renal colic 0/21 (0%) 1/8 (12.5%) 0/21 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 2/21 (9.5%) 0/8 (0%) 0/21 (0%)
    Oropharyngeal pain 1/21 (4.8%) 1/8 (12.5%) 1/21 (4.8%)
    Skin and subcutaneous tissue disorders
    Pruritus 2/21 (9.5%) 0/8 (0%) 0/21 (0%)
    Vascular disorders
    Hypertension 2/21 (9.5%) 0/8 (0%) 4/21 (19%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Clinical Trial Disclosures
    Organization Gilead Sciences
    Phone
    Email ClinicalTrialDisclosures@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01320943
    Other Study ID Numbers:
    • GS-EU-174-0160
    • 2010-021925-12
    First Posted:
    Mar 23, 2011
    Last Update Posted:
    Aug 29, 2017
    Last Verified:
    Jul 1, 2017